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Cuban drug to make debut in U.S. market


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Website: http://www.theglobeandmail.com/servlet/ArticleNews/TPStory/LAC/20040907/RYMCUBA07/TPBusiness/Canadian

Posted on: 09/07/2004

Cuban drug to make debut in U.S. market

In an apparent policy shift, Washington has approved a Havana-developed cancer treatment, LEONARD ZEHR reports

By LEONARD ZEHR

UPDATED AT 1:47 PM EDT Tuesday, Sep 7, 2004

You still can't buy a good Cuban cigar in the United States, but an apparent policy shift in Washington is paving the way for the arrival of experimental cancer treatments from the outcast island country.

In July, the U.S. Department of the Treasury gave CancerVax Corp. of San Diego the green light to license a package of three drugs that were developed at the Centre of Molecular Immunology (CIM) in Havana.

The package included two early stage cancer compounds from YM BioSciences Inc. of Mississauga, which has been CIM's licensing partner since 1995.

CancerVax also picked up a cancer vaccine that YM returned to CIM in 2002 as part of a corporate refocusing.

"This is the first time a Cuban-originated biological product has been licensed by a U.S. company," said YM president and chief executive officer David Allan, referring to CancerVax's two-year lobbying in Congress to drive a wedge in the Helms-Burton Act. The legislation prohibits Americans from any commercial venture that would funnel money to Cuba.

"The astonishing thing to me is that it happened at all."

The shadow of U.S.-Cuban political and trade frictions has hung over YM since it was founded in 1994 to commercialize medical discoveries in Cuba.

Specifically, investors in North America were reluctant to finance development of TheraCIM and several other Cuban cancer treatments because of potential hurdles in winning marketing approval from the U.S. Food and Drug Administration. As a result, the bulk of YM's financing has taken place in Europe, where investors have encouraged the company to diversify beyond Cuba.

While CIM and YM get up-front cash and future royalties if CancerVax's testing succeeds, YM retained ownership of the drug TheraCIM.

TheraCIM is an antibody that targets the epidermal growth factor (EGF) receptor to block tumour growth, a mechanism of action that makes it equivalent to ImClone Systems Inc.'s hot-selling Erbitux cancer drug.

A spokesman for the U.S. State Department said the CancerVax licence was a unique case that recognized the "potential to successfully treat a deadly disease using technology not otherwise available."

As a matter of policy, he said the government will continue to "consider licence requests where there is a potential benefit to U.S. public health."

Mr. Allan said CancerVax's breakthrough is expected to accelerate YM's negotiations to sign a sales and marketing deal for TheraCIM with a U.S. drug company.

"My guess is it will go quite quickly," he said, adding that TheraCIM is the only EGF receptor drug without a marketing partner in the United States. The reason: the U.S. trade embargo against Cuba that prevented companies from even negotiating with YM.

YM has already partnered TheraCIM in Europe with Oncoscience AG of Germany, which is planning several clinical trials this year, including a late-stage study in brain cancer.

The drug has won 10 years of marketing exclusivity if approved, which could help the drug approval process in the United States, analysts say.

"[Brain cancer] is a small market but in oncology, if you get something approved, oncologists tend to use it off-label for other cancers," said Dlouhy Merchant Group analyst Doug Loe.

Sprott Securities analyst David Dean, who initiated coverage of YM in June with a 12-month target price of $7, calls the stock price "dramatically undervalued." It closed Friday at $3.35 on the Toronto Stock Exchange, giving the company a market value of $94.4-million.

"People misunderstand YM because of the early Cuban connection and a so-called failed clinical trial for tesmilifene, and neither of those are applicable any more," he said.

"The YM story has really changed but people are slow to realize it."

YM's flagship tesmilifene drug was discovered at the University of Manitoba and is designed to make chemotherapy drugs work better.

In an earlier late-stage study, the drug failed its primary end point of tumour response in 305 women with metastatic breast cancer.

But after further analysis, scientists found that it had extended patient survival by more than 50 per cent, compared with a control arm, and 143 per cent in women with aggressive breast cancer.

Those results prompted the U.S. Food and Drug Administration to accept the study as one of two needed for approval.

It also gave YM the green light for a second late-stage trial, which only needs to show a 33-per-cent improvement in survival over chemotherapy alone.

Moreover, the FDA gave YM permission to review the test data after 192 deaths, which Mr. Allan figures will occur in mid-2006.

If the drug can show a 50-per-cent improvement in survival, YM can file for approval at that time, setting the stage for a possible 2007 launch. If not, the trial will continue until all 700 patients are studied.

Mr. Dean likes tesmilifene's chances of success and estimates the drug's initial market potential at $300-million (U.S.) a year, climbing to more than $1-billion if it is used with several chemotherapy drugs and also to treat a certain type of prostate cancer.

Mr. Allan said YM is negotiating a co-development deal for the sales and marketing of tesmilifene, with the objective of getting a 50-per-cent share of revenues.

"Our preference is a U.S. biotech company that is ready to launch a cancer product with its own sales force and will need additional products like tesmilifene to sell."




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